# K941234: Non-Mydriatic Retinal Camera

- Pathway: 510(k) (Traditional)
- Applicant: Canon USA, Inc.
- Decided: Jun 7, 1995 after 449 days
- Product code: HKI (Camera, Ophthalmic, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
121 later devices descend from it; 1 cites it directly.
0 of 122 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K980246: Non-Mydriatic Retinal Camera, Model CR6-45NM (1998), 120 descendants of its own
- K014274: Non-Mydriatic Fundus Camera, Model NM-1000 (2002), 96 descendants of its own
- K031629: Canon Non-Mydriatic Retinal Camera, Model CR-Dgi (2003), 92 descendants of its own
- K041367: Topcon Model TRC-NW200 Non-Mydriatic Retinal Camera (2004), 79 descendants of its own
- K062295: Iri Integrated Retinal Imager (2006), 63 descendants of its own

Source page: https://510kreport.com/device/K941234
Methodology: https://510kreport.com/methodology